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Diss Factsheets
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EC number: 473-780-7 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1 December 2006 to 9 January 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP compliant; no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: LLNA
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: B&K Universal Ltd, Hull, UK
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 15 to 23 g
- Housing: individually in suspended solid-floor polypropylene cages furnished with softwood woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 1, 2.5, or 5%
- No. of animals per dose:
- Five
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 5%
- Irritation: None
- Lymph node proliferation response: Not determined
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: The test material will be regarded as a sensitiser if at least on concentration of the test material results in a threefold or greater increase in 3HTdR incorporation compared to control values.
TREATMENT PREPARATION AND ADMINISTRATION: The test material was freshly prepared in the vehicle and the mice were treated by daily application of 25 µl of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days. Five days following the first topic application of the test material all mice were injected via the tail vein with 250 µl of phosphate buffered saline (PBS) containg 3H-methyl thymidine (3HTdR:80µCi/ml, specific activity 2.0 Ci/mmol, GE Healthcare UK Ltd) giving a total of 20 µCi to each mouse.
Five hours later, the draining auricular lymph nodes were excised and processed into PBS. A single cell suspension of lymph node cells was prepared from each mouse by rinsing the cells with 4 ml PBS through a 200-mesh stainless steel gauze into a petri dish. The lymph node cells suspension was transferred to a centrifuge tube and was pelleted at 1400 rpm for ten minutes. The pellet was resuspended in 10 ml PBS and re-pelleted. Cells were precipitated with 3 ml 5% trichloroacetic acid at 4 °C for 18 hours. The precipitates were recovered, resuspended and transferred to 10 ml of scintillation fluid. 3HTdR incorporation was measured by ß-scintillation counting. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control, α-hexylcinnamaldehyde, was considered to be a sensitiser.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Stimulation index for 1%, 2.5% and 5% is 0.94, 0.69 and 1.10, respectively. See also table 14.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean DPM for vehicle control, 1%, 2.5% and 5% are 1988.22, 1862.99, 1366.01 and 2183.85, respectively. See also table 14.
Any other information on results incl. tables
Table 14 - Results LLNA
Concentration (%w/w) in acetone/olive oil 4:1 |
Animal number |
dpm/animal |
Mean dpm/animal (standard deviation) |
Stimulation Index |
Result |
Vehicle |
1-1 |
1445.35 |
1988.22 (±530.51) |
N/A |
N/A |
1-2 |
2144.98 |
||||
1-3 |
2048.27 |
||||
1-4 |
2763.51 |
||||
1-5 |
1539.00 |
||||
1 |
2-1 |
2025.69 |
1862.99 (±594.55) |
0.94 |
Negative |
2-2 |
2504.88 |
||||
2-3 |
1640.39 |
||||
2-4 |
956.94 |
||||
2-5 |
2187.03 |
||||
2.5 |
3-1 |
2797.37 |
1366.01 (±847.83) |
0.69 |
Negative |
3-2 |
749.26 |
||||
3-3 |
1167.96 |
||||
3-4 |
1386.95 |
||||
3-5 |
728.50 |
||||
5 |
4-1 |
2160.63 |
2183.85 (±740.63) |
1.10 |
Negative |
4-2 |
2553.50 |
||||
4-3 |
929.15 |
||||
4-4 |
2450.67 |
||||
4-5 |
2825.32 |
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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